Rani Therapeutics Announces New Preclinical Pharmacokinetic Data Supporting Transenteric Delivery of GLP-1 Incretin Triagonist

-Transenteric delivery of incretin triagonist GLP-1, GIP, glucagon receptors mimicking the RaniPill route of administration elicits rapid weight loss and bioavailability comparable to subcutaneous injection –

– New pharmacokinetic data provides further evidence of the RaniPill platform’s potential to enable oral delivery of multiple obesity treatments –

– Phase 1 study for RT-114, an oral GLP-1/GLP-2 dual agonist for the treatment of obesity, expected to initiate in 2025 –

Excerpt from the Press Release:

SAN JOSE, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) — Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced new pharmacokinetic data from a preclinical study evaluating a GLP-1, GIP and glucagon receptors incretin triagonist with a delivery method mimicking the RaniPill route of administration. A previous study with this incretin triagonist delivered transenterically demonstrated pharmacodynamic effects comparable to subcutaneous injection. Rani also previously completed a study demonstrating oral delivery of GLP-1 receptor agonist with high bioavailability via the RaniPill capsule.

“The pharmacokinetic data announced today combined with the previously announced pharmacodynamic data further highlight the RaniPill’s potential to serve as a novel delivery platform for incretin triagonists, a next generation modality for the treatment of obesity,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “Overall, the totality of RaniPill preclinical data presented to date is promising and provides scientific validation for the potential of the RaniPill to replace painful injections with oral alternatives with differentiated dosing flexibility for multiple obesity drug candidates. Looking ahead, we are focused on execution of a Phase 1 clinical trial for RT-114, a RaniPill capsule containing ProGen’s GLP-1 / GLP-2 dual-agonist, PG-102, and we are evaluating options to move forward with one or more additional molecules in the obesity space.”

Data Highlights

The preclinical study evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of an incretin triagonist (GLP-1, GIP, glucagon receptors) when delivered via an endoscope-guided transenteric administration to mimic the RaniPill route of administration, versus the traditional administration route of subcutaneous (SC) injection. The study was conducted in canines separated into two groups. In Group 1 (N=3), 0.12 mg/kg of drug was administered via transenteric delivery by endoscope. In Group 2 (N=5), 0.12 mg/kg of drug was administered by SC injection. Blood samples were collected over 2 weeks for analysis of serum drug concentrations and various PD and safety biomarkers.

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